Hemostasis clip with collapsible capsule

ABSTRACT

A clipping device includes a capsule including a longitudinal body and a cap mounted over a distal end thereof so that the cap is movable relative to the longitudinal body from a pre-deployed configuration to a deployed configuration in which the cap, is moved proximally relative to the longitudinal body to reduce a length of the capsule. A channel of the cap and a channel of the capsule are substantially aligned with respect to one another. At least proximal portions of a pair of clip arms are received within the channels of the cap and the longitudinal body so that the clip arms are movable relative to the capsule between an open configuration, in which distal ends of the clip arms are separated from one another, and a closed configuration, in which the distal ends of the clip arms are drawn toward one another.

PRIORITY CLAIM

The present disclosure claims priority to U.S. Provisional PatentApplication Ser. No. 62/853,303 filed May 28, 2019; the disclosure ofwhich is incorporated herewith by reference.

FIELD

The present disclosure relates to endoscopic devices and, in particular,relates to endoscopic clipping devices for treating tissue along thegastrointestinal tract.

BACKGROUND

During endoscopic gastrointestinal (GI) procedures, the patient may beat risk of perforation of a wall of the GI tract, or may require closureof the GI tract wall as part of the procedure. Hemostasis clips may beused for hemostasis of, for example, mucosal/sub-mucosal defects,bleeding ulcers, arteries, polyps, diverticula, along with closure ofluminal tract perforations. Depending on the size of the defect,multiple clips may be required.

SUMMARY

The present disclosure relates to a clipping device, comprising acapsule including a longitudinal body and a cap mounted over a distalend thereof so that the cap is movable relative to the longitudinal bodyfrom a pre-deployed configuration to a deployed configuration in whichthe cap, is moved proximally relative to the longitudinal body to reducea length of the capsule. A channel of the cap and a channel of thecapsule being substantially aligned with respect to one another. Theclipping device also includes a pair of clip arms, at least proximalportions of which are received within the channels of the cap and thelongitudinal body so that the clip arms are movable relative to thecapsule between an open configuration, in which distal ends of the cliparms are separated from one another, and a closed configuration, inwhich the distal end of the clip arms are drawn toward one another.

In an embodiment, a distal end of the cap may include a shoulder forabutting the distal end of the longitudinal body to prevent furtherproximal movement of the cap relative to the longitudinal body.

In an embodiment, the clip arms may be biased toward the openconfiguration so that, in the closed configuration, the clip arms drawntoward one another via contact with an interior surface of one of thecap and the longitudinal body.

In an embodiment, a proximal portion of the longitudinal body mayinclude locking windows extending through a wall thereof.

In an embodiment, proximal ends of the clip anus may include lockingtabs which are configured to engage the locking windows of thelongitudinal body when the capsule is in the deployed configuration.

In an embodiment, the cap may be coupled to the longitudinal body via ashear pin configured to fail when the predetermined force is exertedthereon.

In an embodiment, the cap may be coupled to the longitudinal body via apin extending from an interior surface thereof and through a slottedopening extending through a wall along a distal portion of thelongitudinal body, the pin longitudinally slidable from a distal end ofthe slotted opening, in the pre-deployed configuration, to a proximalend of the slotted opening, in the deployed configuration.

In an embodiment, the distal end of the slotted opening may be sized andshaped to correspond to a size and shape of the pin, the distal andproximal ends of the slotted opening connected via a middle portionhaving a width smaller than the distal end of the slotted opening sothat when the predetermined force is exerted on the cap to move thecapsule from the pre-deployed to the deployed configuration, one of thepin and the middle portion deform to permit the pin to be slidproximally along the slotted opening.

In an embodiment, at least one of the clip arms may include an engagingfeature configured to engage a portion of the cap so that, when apredetermined proximal force is exerted thereon, the capsule is movedfrom the pre-deployed configuration to the deployed configuration.

The present disclosure also relates to device for treating a targettissue, comprising a clip including a capsule extending longitudinallyfrom a proximal end to a distal end and including a channel extendingtherethrough. Proximal ends of a pair of clip arms are slidably receivedwithin the channel so that the pair of clip aims are movable between anopen configuration, in which distal ends thereof are separated from oneanother, and a closed configuration, in which the distal ends thereofare moved toward one another. The capsule further includes a cap mountedover a distal end of a longitudinal body so that, when a predeterminedforce is exerted on the cap via engaging features of the clip arms, thecap is moved from a pre-deployed configuration to the deployedconfiguration, in which the cap is moved proximally relative to thelongitudinal body to reduce a length of the capsule. A proximal portionof the device is configured to permit insertion of the clip through aworking channel of an endoscope. The proximal portion includes aflexible shaft extending from a proximal end to a distal end configuredto be releasably coupled to the proximal end of the capsule. A controlmember extends through the flexible shaft to a distal end releasablycoupled to proximal ends of the clip arms so that moving the controlmember longitudinally relative to the flexible shaft moves the clip armsbetween the open and the closed configurations.

In an embodiment, a distal end of the cap may include a shoulder forabutting the distal end of the longitudinal body to prevent furtherproximal movement of the cap relative to the longitudinal body.

In an embodiment, the clip arms may be biased toward the openconfiguration so that the clip arms are constrained toward the closedconfiguration via an interior surface of one of the cap and thelongitudinal body.

In an embodiment, the cap may be coupled to the longitudinal body via ashear pin configured to fail when the predetermined force is exertedthereon.

In an embodiment, the cap may be coupled to the longitudinal body via apin extending from an interior surface thereof and through a slottedopening extending through a wall along a distal portion of thelongitudinal body, the pin longitudinally slidable from a distal end ofthe slotted opening, in the pre-deployed configuration, to a proximalend of the slotted opening, in the deployed configuration.

In an embodiment, the distal end of the slotted opening may be sized andshaped to correspond to a size and shape of the pin, the distal andproximal ends of the slotted opening connected via a middle portionhaving a width smaller than the distal end of the slotted opening sothat when the predetermined force is exerted on the cap to move thecapsule from the pre-deployed to the deployed configuration, one of thepin and the middle portion deform to permit the pin to be slidproximally along the slotted opening.

The present disclosure also relates to a method for treating a targettissue, comprising inserting a clip device through a working channel ofan endoscope to a target site within a body until the clip deviceextends distally past a distal end of the working channel. The clipdevice includes a capsule and a pair of clip arms slidably receivedtherein. The capsule further includes a cap mounted over a distal end ofa longitudinal body. The clip device is moved between an openconfiguration, in which distal ends of the clip arms are separated fromone another, and a closed configuration, in which the distal ends of theclip arms are drawn toward one another, until a target tissue isreceived between the distal ends as desired. The clip arms are drawnproximally into the capsule to move the clip toward the closedconfiguration to grip the target tissue between the clip aims. The clipis moved from a pre-deployed configuration toward a deployedconfiguration which reduces a length of the capsule by moving the cliparms further proximally relative to the so that an engaging feature ofthe clip arms engages the cap and exerts a predetermined proximal forcethereon to move the cap proximally relative to the longitudinal body.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 shows a longitudinal cross-sectional view of the device of FIG.1, in the pre-deployed configuration;

FIG. 2 shows a longitudinal cross-sectional view of the device of FIG.1, in a deployed configuration;

FIG. 3 shows a longitudinal side view of a device according to anexemplary embodiment of the present disclosure;

FIG. 4 shows a longitudinal side view of a capsule of the device of FIG.1, in the pre-deployed configuration;

FIG. 5 shows a longitudinal side view of the capsule of the device ofFIG. 1, in the deployed configuration;

FIG. 6 shows an enlarged partially transparent view of a portion of thecapsule of the device of FIG. 1, in the pre-deployed configuration;

FIG. 7 shows an enlarged partially transparent view of the capsule ofthe device of FIG. 1, in the deployed configuration;

FIG. 8 shows an enlarged partially transparent view of a portion of acapsule of a device according to an alternate embodiment of the presentdisclosure, in a pre-deployed configuration; and

FIG. 9 shows an enlarged partially transparent view of a portion of thecapsule of FIG. 8, in a deployed configuration.

DETAILED DESCRIPTION

The present disclosure may be further understood with reference to thefollowing description and the appended drawings, wherein like elementsare referred to with the same reference numerals. The present disclosureis directed to an endoscopic clipping device for treating tissueperforations, defects and/or bleeds. In some cases, a shorter deployedclip may be preferred to improve visualization of the target site and toallow better maneuverability when placing multiple clips. Exemplaryembodiments of the present disclosure describe a clip comprising cliparms, proximal ends of which are slidably received within a capsule tomove the clip between an open configuration and a closed configurationto clip a target tissue, as desired. As the clip is deployed over thetarget tissue in the closed configuration, the capsule collapses toreduce a length of the deployed clip, improving visibility of a targetsite and maneuverability when placing multiple clips. It should be notedthat the terms proximal and distal, as used herein, are intended torefer to a direction toward (proximal) and away from (distal) a user ofthe device.

As shown in FIGS. 1-7, a clipping device 100 for treating tissue defectscomprises a clip 102 including a pair of clip arms 104, proximal ends108 of which are slidably received within a capsule 106 so that the clip102 may move between an open configuration, in which distal ends 110 ofthe clip arms 102 are separated from one another, and a closedconfiguration, in which the distal ends 110 are drawn toward oneanother. The capsule 106 further comprises a longitudinal body 112 and acap 114 coupled to one another and movable relative to one another froma pre-deployed configuration to a deployed configuration. In oneembodiment, the cap 114 may be coupled to the longitudinal body 112 via,for example, a shear pin 132, which breaks or separates to move thecapsule from the pre-deployed to the deployed configuration. As thecapsule 106 is moved from the pre-deployed to the deployedconfiguration, the cap 114 moves relative to the longitudinal body 112to reduce a length of the capsule 106 upon deployment. The device 100 isreleasably coupled to a proximal portion 116 facilitating insertion ofthe device 100 to a target site, connecting the clip 102 to actuatorsaccessible to a user (i.e., outside the body) to permit the user tocontrol movement of the device 100 between the open and closedconfigurations and to deploy the device clip 102 over target tissue. Theproximal portion 116 may include, for example, a flexible shaft 118extending from a proximal end connected to a handle member (not shown)that remains outside the body, the handle including controls for movingand deploying the device 100 to a distal end 120 releasably coupled to aproximal end 122 of the capsule 106. The proximal portion 116 alsoincludes a control member 124 extending from a proximal end connected tothe controls of the handle member to a distal end 126 connected to theproximal ends 108 of the clip arms 102.

As described above, the capsule 106 includes the longitudinal body 112and the cap 114. The longitudinal body 112 extends from the proximal end122 to a distal end 128 and includes a channel 130 extendingtherethrough. In one embodiment, the proximal end 122 is configured tobe releasably coupled to the distal end 120 of the flexible shaft 118.For example, the proximal end 122 may include tabs 134 that are crimpedradially inward to engage a corresponding portion of a bushing at thedistal end 120 of the flexible shaft 118. The longitudinal body 112 mayalso include locking windows 136 extending laterally through a wallthereof or other structures for engaging locking tabs 150 of the cliparms 104, as will be described in further detail below.

In one embodiment, the cap 114 is mounted over the distal end 128 sothat the cap 114 is movable relative to the longitudinal body 112 fromthe pre-deployed to the deployed configuration. The cap 114 also extendslongitudinally from a proximal end 138 to a distal end 140 with achannel 142 extending longitudinally therethrough so that channels 142,130 of the cap 114 and the longitudinal body 112 are aligned to permitthe clip aims 104 to slide longitudinally therein. In the pre-deployedconfiguration, the cap 114 is in a distal-most position relative to thelongitudinal body 112. As the capsule 106 is moved from the pre-deployedto the deployed configuration, the cap 114 moves proximally relative tothe longitudinal body 112 so that a length of the capsule 106 in thedeployed configuration is shorter than a length of the capsule 106 inthe pre-deployed configuration. In one embodiment, the distal end 140 ofthe cap 114 includes a shoulder 148 configured to engage the distal end128 of the longitudinal body 112 to prevent the distal end 128 of thelongitudinal body 112 from moving distally therepast. In other words,when the shoulder 148 engages the distal end 128 of the longitudinalbody 112, the cap 114 is in a proximal-most position relative to thelongitudinal body 112 and defines a minimum length of the capsule 106.

The cap 114 may be coupled to the distal end 128 of the longitudinalbody 112 in any of a variety of ways. In one embodiment, the cap 114 maybe overmolded to the longitudinal body 112. In one example, as shown inFIGS. 6-7, the cap 114 is overmolded to the distal end 128 of thelongitudinal body 112 via a shear pin 132, in the pre-deployedconfiguration. The shear pin 132 is configured to break and/or separatewhen a predetermined force is exerted thereon. In one embodiment, whenthe clip arms 104 are drawn proximally relative to the capsule 106 tolock and deploy the clip 102, as will be described in further detailbelow, a portion of the one or both clip arms 104 engages the distal end140 of the cap 114 so that a proximal force is exerted thereon. Theproximal force exerted on the cap 114 breaks the shear pin 132 so thatthe cap 114 is freed to move proximally with respect to the longitudinalbody 112, from the pre-deployed to the deployed configuration.

Each of the clip arms 104 extends from the proximal end 108 to thedistal end 110. As described above, proximal portions of the clip arms104 are slidably received within the channels 130, 142 of thelongitudinal body 112 and the cap 114 of the capsule 106. In someembodiments, the proximal ends 108 of the clip arms 104 are slidablyreceived within the longitudinal body 112 to move the clip 102 betweenthe open and closed configurations. For example, as described above, theproximal ends 108 of the clip arms 104 may be coupled to the controlmember 124 (directly or indirectly) so that the clip arms 104 may bemoved between the open and closed configurations via manipulation of thecontrol member 124. In one embodiment, the clip arms 104 are biasedtoward the open configuration so that, in the closed configuration, theclip arms 104 are constrained toward one another via an interior surfaceof the cap 114 and/or the longitudinal body 112. When the clip anus 104are moved distally to extend further out of the capsule 106, the cliparms 114 revert to their biased open configuration.

Each of the clip aims 104 also includes an engaging feature 144configured to engage a portion of the cap 114 to exert a proximal forcethereon when the clip arms 104 are drawn proximally with respect to thecapsule 106. In one embodiment, as shown in FIG. 3, the engagingfeatures 144 extend from a portion of the clip arms 104 so that, whenthe clip arms 104 are drawn proximally relative to the capsule 106, theengaging features 144 abut a portion of a distal face 146 of the cap114. The engaging features 144 are positioned along the clip arms 104 sothat, when the engaging features 144 engage the cap 114, the clip arms104 are drawn toward the closed configuration. In one example, theengaging features 144 are configured as wings extending fromlongitudinal edges of the clip arms 104.

Proximal ends 108 of the clip arms 104 also include locking tabs 150extending therefrom. The proximal ends 108 in this embodiment are biasedoutward, away from a centerline of the capsule 106, but are restrainedvia the distal end 126 of the control member 124 until the clip 102 isbeing deployed. As will be described in further detail below, when it isdesired to lock the clip 102 in the closed configuration, the clip arms104 are moved proximally relative to the capsule 106 until the proximalends 108 of the clip arms 104 are released from the control member 124and the locking tabs 150 are permitted to spring outward and engage thelocking windows 136 of the longitudinal body 112.

According to an exemplary method utilizing the device 100, the clip 102is inserted through, for example, a working channel of an endoscope to atarget site within a body while the handle member remains exterior tothe body. The clip 102 is inserted through the working channel in theclosed configuration. Once the clip 102 has reached the target site, theclip arms 104 are extended distally out of the capsule 106 and moveunder their natural bias toward the open configuration so that targettissue may be received between the clip arms 104. The clip 102 may bemoved between the open and closed configurations by extending thecontrol member 124 distally or withdrawing it proximally until a desiredportion of target tissue is positioned between the clip arms 104, asdesired. At this point, the clip 102 is drawn into the closedconfiguration to grip this portion of target tissue between the distalends 110 of the clip arms 104 as desired. The clip 102 may be movedtoward the locked configuration by, for example, drawing the controlmember 124 further proximally relative to the capsule 106 until theengaging features 144 engage the cap 114, as described above, exerting aproximal force on the cap 114 to break, separate or otherwise cause theshear pin 132 to fail. Upon breaking/separating of the shear pin 132,the cap 114 moves proximally relative to the longitudinal body 112 fromthe pre-deployed configuration to the deployed configuration, collapsingthe capsule 106 and reducing a length of the capsule 106.

When the shoulder 148 of the cap 114 contacts the distal end 128 of thelongitudinal body 112 and prevents the cap 114 from moving furtherproximally relative to the longitudinal body 112, the clip 102 is lockedand deployed. According to one example, when the shoulder 148 engagesthe longitudinal body 112, the proximal force on the control member 124causes the control member 124 to release from the proximal ends 108 ofthe clip arms 104, allowing the proximal ends 108 to revert to theirbiased configuration so that the locking tabs 150 engage the lockingwindows 136, thereby locking the clip 102 in the collapsed, closedconfiguration. The control member 124 is drawn proximally until anenlarged portion 152 at the distal end 126 of the control member 124 ispositioned within the proximal end 122 of the longitudinal body 112 ofthe capsule 106 to move the inwardly crimped tabs 134 outward (i.e.,away from a centerline of the capsule 106), out of engagement with, forexample, the bushing at the distal end 120 of the flexible shaft 118.Further proximal motion of the control member 124 separates the controlmember 124 from the clip 102, freeing the clip 102 from the proximalportion of the device 100 and freeing it to remain in the body as therest of the device 100 is removed from the body.

Although the exemplary embodiments show and describe a specificdeployment mechanism, it will be understood by those of skill in the artthat the clip 102 may be deployed via any of a number of deploymentmechanisms so long as the capsule 106 collapses to reduce a lengththereof during the deployment process. Specifically, as described above,the capsule 106 is collapsed via the proximal motion of the cap 114relative to the longitudinal body. Although the exemplary embodimentdescribes and shows mounting of the cap 114 over the distal end 128 ofthe longitudinal body 112 in the pre-deployed configuration via a shearpin 132, it will be understood by those of skill in the art that the cap114 may be temporarily fixed relative to the longitudinal body 112 inthe pre-deployed configuration and moved toward the deployedconfiguration via any of a number of mechanisms.

For example, as shown in FIGS. 8-9, a capsule 206 may be substantiallysimilar to the capsule 106 described above, and may be utilized in placeof the capsule 106 in the device 100. Similarly to the capsule 106, thecapsule 206 includes a cap 214 mounted over a distal end 228 of alongitudinal body 212 and movable relative thereto from a pre-deployedconfiguration to a deployed configuration. The cap 214 and thelongitudinal body 212 may be substantially similar to the cap 114 andlongitudinal body 112 described above with respect to the capsule 106.Rather than being mounted over the longitudinal body in the pre-deployedconfiguration via a shear pin, however, the cap 214 is coupled to thelongitudinal body 212 via a pin 232 and slot 254.

In one embodiment, a distal portion of the longitudinal body 112includes the slot 254 extending longitudinally through a wall thereof.The pin 232 extends from an interior surface of the cap 214 and throughthe slot 254 to couple the cap 214 to the longitudinal body 112. In apre-deployed configuration, the pin 232 extends through a distal portion256 of the slot 254 while in the deployed configuration, the pin 232extends through the proximal portion 258 of the slot 254. The distal andproximal portions 256, 258 of the slot 254 are sized and shaped tocorrespond to a size and shape of the pin 232 received therein. A middleportion 260 of the slot 254 connecting the distal and proximal portions256, 258 has a width smaller than a width of each of the distal andproximal portions 256, 258. In other words, where the pin 232 iscylindrical, a width of the middle portion 260 is smaller than adiameter of the pin 232 so that, to be moved from the pre-deployed tothe deployed configuration, a predetermined force must be exerted on thepin 232, causing one of the pin 232 and/or the middle portion 260 toelastically deform allowing the pin 232 to slide along the middleportion 260 from the distal portion 256 to the proximal portion 258.

The capsule 206 may be utilized in substantially the same manner as thecapsule 106. For example, as described above, in the pre-deployedconfiguration, the pin 232 is in the distal portion 256 of the slot 254so that the cap 214 is in a distal-most position relative to thelongitudinal body 212. Once the clip 102 has gripped a target tissue asdesired, however, the clip arms 104 are drawn farther proximallyrelative to the capsule 206 until the engaging features 144 of the clipaims 104 engage the cap 214, exerting a proximal force on the cap 214which deforms the pin 232 or the middle portion 260 of the slot 254permitting the pin 232 to slide from the distal portion 256, through themiddle portion 260 and to the proximal portion 254. When the pin 232 isreceived within the proximal portion 254, the cap 214 is in theproximal-most position relative to the longitudinal body 212, in thecollapsed configuration. As described above, the clip 102 may then belocked and deployed, in the collapsed and closed configuration, as willbe understood by those of skill in the art.

It will be apparent to those skilled in the art that variousmodifications may be made in the present disclosure, without departingfrom the scope of the disclosure.

What is claimed is:
 1. A clipping device, comprising: a capsule including a longitudinal body and a cap mounted over a distal end thereof so that the cap is movable relative to the longitudinal body from a pre-deployed configuration to a deployed configuration in which the cap is moved proximally relative to the longitudinal body to reduce a length of the capsule, a channel of the cap and a channel of the longitudinal body being substantially aligned with respect to one another; and a pair of clip arms, at least proximal portions of which are received within the channels of the cap and the longitudinal body so that the clip arms are movable relative to the capsule between an open configuration, in which distal ends of the clip arms are separated from one another, and a closed configuration, in which the distal ends of the clip arms are drawn toward one another.
 2. The device of claim 1, wherein a distal end of the cap includes a shoulder for abutting the distal end of the longitudinal body to prevent further proximal movement of the cap relative to the longitudinal body.
 3. The device of claim 1, wherein the clip arms are biased toward the open configuration so that, in the closed configuration, the clip arms drawn toward one another via contact with an interior surface of one of the cap and the longitudinal body.
 4. The device of claim 1, wherein a proximal portion of the longitudinal body includes locking windows extending through a wall thereof.
 5. The device of claim 1, wherein proximal ends of the clip arms include locking tabs which are configured to engage the locking windows of the longitudinal body when the capsule is in the deployed configuration.
 6. The device of claim 1, wherein the cap is coupled to the longitudinal body via a shear pin configured to fail when the predetermined force is exerted thereon.
 7. The device of claim 1, wherein the cap is coupled to the longitudinal body via a pin extending from an interior surface thereof and through a slotted opening extending through a wall along a distal portion of the longitudinal body, the pin longitudinally slidable from a distal end of the slotted opening, in the pre-deployed configuration, to a proximal end of the slotted opening, in the deployed configuration.
 8. The device of claim 7, wherein the distal end of the slotted opening is sized and shaped to correspond to a size and shape of the pin, the distal and proximal ends of the slotted opening connected via a middle portion having a width smaller than the distal end of the slotted opening so that when the predetermined force is exerted on the cap to move the capsule from the pre-deployed to the deployed configuration, one of the pin and the middle portion deform to permit the pin to be slid proximally along the slotted opening. 